The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions(periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques(manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions.

In the analysis, the effectiveness term will be quality adjusted life years, which is the product of the quality of life utility associated with a health state and the length of time lived in that state, summed over time. Utilities are a measure of preference for a health state and range from 0 (death) to 1 (perfect health). In this analysis, utilities will be derived from EQ-5D scores. The cost-effectiveness ratio (or, in this analysis, the cost-utility ratio) is the difference in cost divided by the difference in quality-adjusted life-years between intervention groups.

Subjects will rate their worst knee pain in the last 24 hours using an 11 point numeric pain rating scale with 0 representing "no pain" and 10 representing " the worst pain imaginable."

Global Rating of Change [ Time Frame: Change from baseline to 9 weeks, 1 and 2 years ] [ Designated as safety issue: No ]

The global rating of change is a 15 item scale in which subjects will rate the degree to which their knee condition has changed from the time treatment was initiated to the present.24 The subject responds to the following query: "Please rate your overall knee's condition from the time you began treatment until now (check only one)." The items range from "A very great deal better" to "A very great deal worse."

Change in Timed Up and Go Test Time [ Time Frame: Change from Baseline to 9 weeks and 1 year ] [ Designated as safety issue: No ]

On the command "go" subjects will stand up from a chair, walk 3 meters, turn around, return to the chair and sit down. The time it takes to complete this task will be recorded.

Change in 30 second time chair rise test. [ Time Frame: Change from Baseline to , 9 weeks, 1 year ] [ Designated as safety issue: No ]

Subjects will be seated with their arms crossed in front of their chest. On the command "go" subjects will stand up and sit down for as many trials as they can in a 30 second period.

Change in Self-paced Walk Test Time [ Time Frame: Change from Baseline to 9 weeks, 1 year ] [ Designated as safety issue: No ]

Subjects will walk 4 lengths of a 10 meter indoor course in response to the instructions, "Walk as quickly as you can without overexerting yourself."

Change in Pain belief screening instrument [ Time Frame: Change in Baseline to 1 year ] [ Designated as safety issue: No ]

7 item instrument that queries the subject about their pain and how they believe pain limits or does not limit their ability to perform daily activities, social and liesure interactions, mood, etc.

Change in Beck Anxiety Index (BAI) [ Time Frame: Change from Baseline to 1 year ] [ Designated as safety issue: No ]

The CES-D is a 20-item self-report depression scale, each item scored 0-3, with higher scores representing greater symptoms of depression.

Change in EQ-5D [ Time Frame: Change from Baseline to 1 and 2 years ] [ Designated as safety issue: No ]

The EQ-5D is a generic health-related quality of life measure. The EQ-5D consists of the following five dimensions: 1) Mobility, 2) Self-care, 3) Usual activities, 4) Pain/discomfort, and 5) Anxiety/depression (AD).Each dimension has three possible levels (i.e., 1, 2, or 3), representing "no problems," "some problems," and "extreme problems," respectively. Respondents are asked to choose one level that reflects their "own health state today" for each of the five dimensions.

Responder criteria included 1) greater than or equal to 50% improvement in WOMAC pain or WOMAC function and an absolute improvement of greater than or equal to 20, or 2) improvement in at least 2 of the following 3 scores: 20% improvement in pain and absolute change ≥ 10 on WOMAC pain score, 20% improvement in pain and absolute change ≥ 10 on WOMAC function score, or moderate or greater improvement (≤ 4) on a 15 point global rating of change scale.

The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

Active Comparator: exercise + manual therapy

Subjects in this group receive exercise combined with manual therapy techniques for 12 sessions in 9 weeks.

Other: Exercise

The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

Other: manual therapy

The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.

Experimental: exercise + booster

subjects in this arm will receive exercise sessions delivered with booster sessions (8 sessions in the first 9 weeks, 2 sessions at 5 months, 1 session at 8 months, and 1 session at 11 months).

Other: Exercise

The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

Experimental: exercise + manual therapy + booster

Subjects in this arm will receive exercise combined with manual therapy techniques and booster sessions.

Other: Exercise

The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

Other: manual therapy

The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.

Detailed Description:

Exercise therapy (ET) is effective as the first line of treatment for reducing pain and disability in patients with knee osteoarthritis (OA), but studies show its effects diminish considerably over time. 'Booster' intervention sessions (periodic face-to-face follow-up appointments following discharge from supervised therapy designed to review and progress the patient's home program, troubleshoot problems with the program, etc.) have been recommended to make beneficial effects endure however this recommendation has not been adequately tested. There are also indications that manual therapy (MT), manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, and passive stretching, when combined with ET, may improve the overall effectiveness of rehabilitation for reducing pain and disability, and, may significantly delay or reduce the need for total knee arthroplastic surgery and reduce medication intake in people with knee OA. However, current published evidence-based treatment guidelines indicate there is not enough data to make a definitive recommendation regarding the use of MT with ET in rehabilitation programs. Therefore, the overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions in the delivery of ET, and supplementing ET with MT techniques.The study will be a multi-center,randomized clinical trial, using a 2 x 2 factorial design (factor 1 = booster vs no booster, factor 2 = ET alone vs ET + MT). Three hundred subjects (100 per study site) with knee OA will be randomized to one of the following groups: 1) ET - no booster, 2) ET - with booster, 3) MT + ET - no booster sessions, 4) MT + ET - with booster sessions. Clinical outcome measures (WOMAC, knee pain, global rating of change and performance-based measures of function) will be taken at baseline (prior to randomization), at the completion of the initial therapy sessions (9 weeks) and at 1 year follow-up. The primary endpoint for clinical outcome will be the WOMAC at 1 year.For the cost effectiveness analysis, the primary cost outcome will be osteoarthritis treatment costs from the societal perspective, which will include health system costs for implementing each intervention, medical/surgical costs (primary, secondary, and tertiary care costs), and personal costs to participants (travel, non-funded medications, time off work, and quality-of-life burdens). The primary effectiveness outcome measure will be quality-adjusted life-years (QALYs), derived using quality of life utilities from EQ-5D scores. Cost and effectiveness values between interventions will be compared via incremental cost-effectiveness ratios, yielding incremental costs per QALY gained when a given intervention is chosen. Secondary analyses will examine cost-effectiveness from health system and from patient perspectives. Cost and effectiveness data will be obtained at 1 year and 2 year follow-ups. The 2 year follow-up will be the primary endpoint for the cost-effectiveness analysis.

Eligibility

Ages Eligible for Study:

40 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

40 years of age or older

Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the following 6 criteria:

age > 50 years,

morning stiffness of < 30 minutes,

crepitus on active movement,

tenderness of the bony margins of the joint,

bony enlargement of the joint noted on exam,

lack of palpable warmth of the synovium. Based on this criteria, a subject who is less than 50 years but has knee pain and 3 of the other 5 criteria would also be classified as having knee OA.

have complaints of low back pain or other lower extremity joint pain that affects function at the time of recruitment,

have a history of neurological disorders that would affect lower extremity function (stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),

are women who are pregnant.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314183

Locations

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

United States, Texas

Army-Baylor University

San Antonio, Texas, United States

United States, Utah

Intermountain Healthcare

Salt Lake City, Utah, United States

Sponsors and Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:

G. Kelley Fitzgerald, PT, PhD

University of Pittsburgh

Principal Investigator:

Julie M Fritz, PT, PhD

Intermountain Healthcare, Salt Lake City, UT

Principal Investigator:

John D Childs, PT, PhD

Army-Baylor University, San Antonio, TX

Principal Investigator:

J. Haxby Abbott, PT, PhD

University of Otago, Dunedin, New Zealand

More Information

Responsible Party:

g. kelly fitzgerald, Professor, Department of Physical Therapy, University of Pittsburgh, Agency for Healthcare Research and Quality (AHRQ)